Aggressive Fluid Hydration for the Prevention of Post-ERCP Pancreatitis

Pancreatitis Clinical Trial

Official title:

Aggressive Fluid Hydration for the Prevention of Post-ERCP Pancreatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02821546
• Other study ID #: Si416/2014
• Status: Completed
• Phase: Phase 3
• First received: May 27, 2016
• Last updated: March 26, 2017
• Start date: August 2014
• Est. completion date: February 2017

Study information

• Verified date: March 2017
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aggressive hydration with lactated Ringer's solution (LRS) has been shown in a preliminary research to reduce the incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. This randomized, controlled trial was designed to assess the effect of peri-procedural aggressive intravenous hydration with LRS on the incidence of post ERCP pancreatitis.

Description:

Patients underwent first-time ERCP were randomly assigned (1:1) to receive either LRS at a rate of 150 ml/hr starting 2 hours prior to procedure, and continued during and after procedure to complete 24 hours (aggressive hydration) or LRS at a rate calculated by the Holliday-Segar method given peri-procedurally as described earlier (standard hydration). Visual analog scale, serum amylase, lipase, C-reactive protein (CRP), and urine analysis were assessed prior to procedure and 24 hours after. The primary endpoint was post ERCP pancreatitis defined as new or increased epigastric pain persisting for ≥24 hours, elevation of amylase or lipase >3 times the upper limit of normal.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients at age between 18-65 years old undergoing first time ERCP

Exclusion Criteria:

• Ongoing acute pancreatitis

• Chronic pancreaittis

• Prior sphincterotomy

• Ongoing hypotension including those with sepsis

• Cardiac insufficiency (CI, >NYHA Class II heart failure)

• Renal insufficiency (RI, creatinine clearance <40mL/min)

• Severe liver dysfunction (albumin < 3mg/dL)

• Respiratory insufficiency (defined as oxygen saturation < 90%)

• Pregnancy

• Hyponatremia (Na+ levels < 130mEq/L))

• Hypernatremia (Na+ levels > 150mEq/L)

Related Conditions & MeSH terms

• Pancreatitis

Intervention

Drug:
• Lactated Ringer's solution
Standard fluid hydration with Lactated Ringer's solution is calculated based on Holiday Segar's equation Aggressive hydration with Lactated Ringer's solution is defined as administration of 150 ml/hour of fluid

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

Adler DG, Baron TH, Davila RE, Egan J, Hirota WK, Leighton JA, Qureshi W, Rajan E, Zuckerman MJ, Fanelli R, Wheeler-Harbaugh J, Faigel DO; Standards of Practice Committee of American Society for Gastrointestinal Endoscopy.. ASGE guideline: the role of ERCP in diseases of the biliary tract and the pancreas. Gastrointest Endosc. 2005 Jul;62(1):1-8. — View Citation

Buxbaum J, Yan A, Yeh K, Lane C, Nguyen N, Laine L. Aggressive hydration with lactated Ringer's solution reduces pancreatitis after endoscopic retrograde cholangiopancreatography. Clin Gastroenterol Hepatol. 2014 Feb;12(2):303-7.e1. doi: 10.1016/j.cgh.2013.07.026. — View Citation

Elmunzer BJ, Scheiman JM, Lehman GA, Chak A, Mosler P, Higgins PD, Hayward RA, Romagnuolo J, Elta GH, Sherman S, Waljee AK, Repaka A, Atkinson MR, Cote GA, Kwon RS, McHenry L, Piraka CR, Wamsteker EJ, Watkins JL, Korsnes SJ, Schmidt SE, Turner SM, Nicholson S, Fogel EL; U.S. Cooperative for Outcomes Research in Endoscopy (USCORE).. A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med. 2012 Apr 12;366(15):1414-22. doi: 10.1056/NEJMoa1111103. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post ERCP pancreatitis	Post ERCP pancreatitis is defined as hyperamylasemia (amylase >3 times the upper limit of normal [300 U/L]) and pancreatic pain (epigastric abdominal pain radiating to the back scored by patient as development of or increase of pain =3 on a 0-10 visual analogue pain scale and persisting for =24 hours after ERCP). In those who had pain before the procedure, pancreatic pain is defined as an increase of =3 on the 0-10 visual analogue scale.	24 hours
Secondary	severity of post ERCP pancreatitis	severity is defined by length of hospital stay, mild pancreatitis is defined by hospitalization of 48 hours, moderate pancreatitis is defined by hospitalization of more than 48 hours without additional intervention, severe pancreatitis is defined by hospitalization of greater than 72 hours and/or requiring intervention	24 hours